Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. Follow-up on corrective actions derived from investigations through completion.
Conducting and documenting the investigation.
May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
Other duties as assigned
BS in science, PM skills, Complaints experience within medical devices, detailed orientated.
Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
Accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution.
Ensures quality of complaint records
Applies analytical skills to evaluate complex situations using multiple sources of information
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter expert assessments
Escalates potential Quality issues to Management
Owns complex quality record content
Determines situations which require escalation to management
Determines when a complaint dictates further investigation
Works under minimal direction
Proposes revisions to SOPs in area of responsibility
Doctorate degree OR
Master’s degree & 2 years of directly related experience OR
Bachelor’s degree & 4 years of directly related experience OR
Associate’s degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to oversee multiple projects simultaneously
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to travel +/- 10% of time to domestic and international Amgen sites
"This posting is for Contingent Worker, not an FTE"